Oxaliplatin in Treating Women With Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00006121
First received: August 3, 2000
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating women who have advanced or metastatic breast cancer that has not responded to previous chemotherapy.


Condition Intervention Phase
Breast Cancer
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 18
Study Start Date: May 2000
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the therapeutic activity of oxaliplatin in patients with advanced or metastatic breast cancer following failure of anthracycline/taxane based chemotherapy.
  • Determine objective response, duration of response, and time to progression in these patients when treated with this regimen.
  • Determine the acute side effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks until disease progression and then every 3 months for survival.

PROJECTED ACCRUAL: A total of 27-40 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced or metastatic breast cancer
  • Bidimensionally measurable disease

    • At least one lesion at least 2 cm in one dimension by CT scan or MRI
  • Must have failed prior anthracycline/taxane based chemotherapy as defined by one of the following:

    • Stage IV disease treated with anthracycline/taxane combination as first line therapy for advanced or metastatic disease
    • Stage IV disease treated with first line anthracycline therapy and second line taxane therapy for advanced or metastatic disease
    • Any adjuvant treatment other than anthracycline based therapy followed by anthracycline/taxane combination as first line therapy for advanced or metastatic disease
    • Any adjuvant therapy other than anthracycline based therapy followed by first line anthracycline based therapy and second line taxane based therapy for advanced or metastatic disease
    • Adjuvant anthracycline based therapy followed by relapse after 6 months treated with anthracycline/taxane combination as first line therapy or first line anthracycline based therapy and second line taxane based therapy for advanced or metastatic disease
    • Adjuvant anthracycline based therapy followed by relapse within 6 months treated with first line taxane based therapy for advanced or metastatic disease
  • Disease progression within 6 months of last taxane based chemotherapy
  • No brain metastases
  • Hormonal receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN in case of liver metastases)

Renal:

  • Creatinine less than 1.25 times ULN

Cardiovascular:

  • LVEF at least 50% if prior total dose of doxorubicin 550 mg/m2 or greater, epirubicin 900 mg/m2 or greater, or pirarubicin 700 mg/m2 or greater
  • No prior or active congestive heart failure, myocardial infarction, or angina
  • No uncontrolled hypertension or arrhythmia

Other:

  • No unstable systemic disease
  • No active infection
  • No grade 2 or greater peripheral neuropathy
  • No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior high dose chemotherapy with hematopoietic rescue
  • No concurrent immunotherapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) for prevention of neutropenia

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • At least 1 prior taxane based chemotherapy for advanced or metastatic disease
  • No prior high dose chemotherapy with hematopoietic rescue
  • No prior platinum based chemotherapy
  • No prior taxane chemotherapy other than docetaxel or paclitaxel
  • No prior adjuvant or neoadjuvant therapy with taxane/anthracycline based combination chemotherapy

Endocrine therapy:

  • No concurrent steroids except in case of allergy prevention, emesis prophylaxis, or long term treatment for more than 3 months prior to study
  • No concurrent hormonal anticancer therapy

Radiotherapy:

  • No prior radiotherapy to study site unless evidence of disease progression
  • Concurrent local radiotherapy allowed for pain relief

Surgery:

  • At least 4 weeks since prior major surgery

Other:

  • At least 4 weeks since prior anticancer and/or investigational drug
  • No concurrent bisphosphonates unless started at least 2 months prior to study
  • No other concurrent anticancer therapy
  • No other concurrent experimental drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006121

Locations
Austria
Kaiser Franz Josef Hospital
Vienna (Wien), Austria, A-1100
Belgium
Institut Jules Bordet
Brussels (Bruxelles), Belgium, 1000
France
CHU de la Timone
Marseille, France, 13385
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Centre Eugene Marquis
Rennes, France, 35064
Germany
Universitats-Krankenhaus Eppendorf
Hamburg, Germany, D-20246
Israel
Rambam Medical Center
Haifa, Israel, 31096
Schneider Children's Medical Center of Israel
Petah-Tikva, Israel, 49202
Slovenia
Institute of Oncology, Ljubljana
Ljubljana, Slovenia, Sl-1000
United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Pierre Fumoleau, MD, PhD Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  More Information

No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00006121     History of Changes
Other Study ID Numbers: EORTC-16001-10005, EORTC-16001
Study First Received: August 3, 2000
Last Updated: July 23, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage III breast cancer
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014